Methods and devices for puncturing tissue

A transseptal puncture device for puncturing tissue and for use with a supporting member for supporting the puncture device comprising a lumen for receiving the puncture device and a distal tip marker which is visible under an imaging system, the assembly comprising:

• an electrically conductive elongate mandrel;
• at least one proximal marker positioned at a proximal portion of the mandrel;
• at least one distal end marker positioned at a distal portion of the mandrel, wherein the distal end marker is visible under an imaging system;
• and
• a clear layer of insulation covering the mandrel and the at least one proximal marker, the clear layer not covering the distal end of the mandrel such that the distal end of the mandrel is electrically exposed to define a distal tip electrode,
• wherein the portions of the transseptal puncture device at and adjacent the at least one proximal marker have a constant diameter;
• wherein the puncture device is capable of being insertable within the lumen of the supporting member and being selectively usable in co-operation therewith during a portion of a procedure for puncturing tissue and wherein the puncture device is usable independently therefrom during another portion of the procedure;
• and
• wherein when the puncture device is inserted within the lumen, the at least one proximal marker allows the puncture device to be positioned relative to a proximal end of the supporting member, and the at least one distal tip marker and the at least one distal end marker allows the puncture device to be positioned relative to the supporting member by using the imaging system.

A method of confirming a position of a tip of a transseptal puncture device relative to a supporting member wherein the transseptal puncture device has at least one proximal marker which is visible to a naked eye and a distal tip marker which is visible under an imaging system and the supporting member has a distal end marker which is visible under the imaging system, the method comprising the steps of:

• (i) positioning the elongate transseptal puncture device relative to a proximal end of the supporting member using the proximal marker without an imaging system in a macro-positioning step;
• (ii) turning on the imaging system;
• and
• (iii) positioning a distal tip of the elongate transseptal puncture device relative to an end of introducer by viewing the distal tip marker and distal end marker using the imaging system in a micro-positioning step.

A method for puncturing a target tissue with a puncture device comprising at least one proximal marker, the method comprising the steps of:

• (i) accessing a region of tissue within a patient's body by advancing the puncture device into the region of tissue;
• (ii) advancing a supporting device over the puncture device to support the puncture device, the supporting device comprising a lumen for receiving the puncture device;
• (iii) positioning the puncture device relative to a proximal end of the supporting member using the proximal marker without an imaging system in a macro-positioning step;
• (iv) positioning a distal end of the puncture device and a distal end of the supporting member at the target tissue site;
• (v) puncturing through the target tissue site using the puncture device, wherein the supporting member supports the puncture device through the puncturing.

A method for puncturing tissue, the method comprising the steps of:

• advancing a flexible puncture device comprising a proximal marker into a region of tissue;
• advancing a sheath and a supporting member over the flexible puncture device into the region of tissue;
• withdrawing the flexible puncture device into the supporting member by using the proximal marker to determine the relative position between the flexible puncture device and the supporting member;
• positioning the flexible puncture device, the sheath and the supporting member as an assembly at a target tissue site in the region of tissue;
• Applying pressure on the target tissue site to tent using the supporting member;
• advancing the flexible puncture device to a puncture position using the proximal marker to determine the relative position between the flexible puncture device and the supporting member;
• creating a puncture in the target tissue site and advancing the flexible puncture device through the puncture;
• and
• advancing the sheath and supporting member over the flexible puncture device to cross through the puncture.

A method for carrying out a transseptal puncture, comprising the steps of:

• advancing an RF guidewire comprising a proximal marker into a superior vena cava;
• advancing a sheath and dilator over the RF guidewire into the superior vena cava to form an assembly;
• withdrawing the RF guidewire into the dilator by using the proximal marker to determine the relative position between the flexible puncture device and the supporting member;
• dropping the assembly down from the superior vena cava into a heart to locate a fossa on a septum of the heart;
• tenting the fossa using the dilator;
• advancing the RF guidewire to puncture position for puncturing the fossa by using the proximal marker to determine the relative position between the flexible puncture device and the supporting member;
• puncturing the fossa using energy delivered by the RF guidewire;
• advancing the RF guidewire through the puncture;
• and
• advancing the sheath and dilator over the RF guidewire to cross the sheath and dilator through the puncture.

A method is provided for carrying out a transseptal puncture, the method comprising:

• advancing an RF guidewire into a superior vena cava;
• advancing a sheath and dilator over the RF guidewire into the superior vena cava;
• inserting a stylet in the dilator until it reaches a stop;
• withdrawing the RF guidewire into the stylet by using the proximal marker to determine the relative position between the flexible puncture device and the supporting member;
• dropping down from the superior vena cava into a heart to locate a fossa on a septum of the heart;
• tenting the fossa using the dilator;
• advancing the RF guidewire to a puncture position for puncturing the fossa by using the proximal marker to determine the relative position between the flexible puncture device and the supporting member;
• puncturing the fossa using energy delivered by the RF guidewire
• advancing the RF guidewire through the puncture;
• advancing the sheath and dilator over the RF guidewire to allow the sheath and dilator to cross through the puncture;
• and
• withdrawing the stylet.